FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 3990118
·
Received August 7, 2014
Report
- Report Number
- 2649622-2014-08793
- Event Type
- Injury
- Date Received
- August 7, 2014
- Date of Event
- May 29, 2014
- Report Date
- May 29, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6947M62 LEAD, IMPLANTED: (B)(6) 2013; DTBB1D4 ICD, IMPLANTED: (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED OFF DUE TO THE PATIENT EXPERIENCING DIAPHRAGMATIC STIMULATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463045 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Required Intervention | 5076-52 LEAD |